Job Description
Join a Leading Innovator in Biopharmaceutical R&D
Are you a detail-oriented expert in clinical data integrity? Novatech Pharma Solutions is seeking a Senior Clinical Data Manager to join our dynamic team in Cambridge, MA. In this pivotal role, you will oversee the end-to-end lifecycle of clinical data, ensuring compliance with global regulatory standards while driving the efficiency of our drug development programs.
We are committed to accelerating the delivery of life-changing therapies. As a Senior CDM, you will bridge the gap between statistical programming and data operations, playing a critical role in shaping the future of our clinical trials.
Why Join Us?
- Competitive salary and equity package.
- Comprehensive health, dental, and vision insurance.
- Flexible work arrangements and remote-first culture.
- Continuous learning and professional development opportunities.
Responsibilities
- Lead the design, implementation, and maintenance of clinical databases for Phase I-IV trials, adhering to CDISC standards (SDTM, DEFINE/ADaM).
- Execute comprehensive data validation plans, including range checks, consistency checks, and logical edits, to ensure data integrity.
- Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs, to resolve data queries and discrepancies.
- Oversee the data cleaning process and ensure timely delivery of high-quality datasets for statistical analysis and regulatory submissions.
- Mentor junior Data Managers and Data Analysts, fostering a culture of excellence and continuous improvement.
- Manage vendor relationships for third-party data management services, ensuring deliverables meet project timelines and quality metrics.
Qualifications
- Master’s degree in Biostatistics, Life Sciences, or a related field; Bachelor’s degree with significant relevant experience is also acceptable.
- Minimum of 5+ years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Expert knowledge of CDISC standards (SDTM, DATA, DEFINE/ADaM) and regulatory guidelines (FDA 21 CFR Part 11, GxP).
- Proficiency in data management tools such as Rave, Oracle Clinical, or RedCap.
- Strong proficiency in statistical programming languages (SAS, R, or Python) for data manipulation and analysis.
- Excellent communication skills, with the ability to present complex data issues to non-technical stakeholders.